Partnering with Community Health Centers to prevent ECC Abstract The national public health agenda, as stated in Healthy People 2010. includes the goal to reduce the prevalence of children with dental caries in their primary teeth to 11% or less (goal 21-1 a). Unfortunately, uptake of the dietary and hygiene behavioral changes needed to prevent early childhood caries (ECC) has been limited, especially among the children most vulnerable to ECC, so that prevalence of the disease remains unacceptably high. However, recent efforts to address the problem of ECC in the medical care setting have been successful suggesting that this is a fruitful direction to pursue. Considering that about 95% of American children under age 6 attend regular well-child visits, pediatricians are potential allies to reduce risk for the disease. Accordingly, the American Academy of Pediatrics has adopted a policy supporting pediatricians' use of caries risk assessment and referral to a dental home. Recent research has documented two efficacious strategies for reducing ECC incidence. First, there is compelling evidence from several randomized controlled trials that fluoride varnish (FV) significantly reduces the incidence of ECC. Given this, and because fluoride varnish applications are safe, cheap and easy to administer even in non-dental settings, fluoride varnish applications should play a key role in the prevention of ECC. Second, our group recently found that training of pediatric clinicians to provide patient centered counseling (PCC) to reduce ECC risk factors (a counseling approach designed to enhance clinician and patient self-efficacy regarding behavioral change) resulted in a greater than 40% reduction in ECC incidence over 2 years among young White, African American, Asian and Latino children. However, the efficacy of this approach has not been tested in a randomized clinical trial. Furthermore, although prior studies have shown that multifaceted interventions including strategies to improve adherence to recommended health behaviors are likely to be the most successful in both changing individual and health care provider behavior, this has not been comprehensively evaluated in the context of ECC prevention. Importantly, prior efforts did not evaluate the factors necessary for widespread implementation and dissemination of such strategies, including FV application and PCC in relevant settings. However, such knowledge is urgently needed to widely disseminate efficacious interventions to children nationwide in the future. We hypothesize that patient centered counseling by pediatric clinicians during well-child visits will be effective in reducing the incidence of ECC in children aged 1 to 3 years over and above any reduction in ECC incidence achieved by regular fluoride varnish applications. To test this hypothesis, we propose a cluster randomized community-based intervention study. We will train pediatric clinicians (both physicians and nurses) to apply fluoride varnish and to use patient centered counseling to reduce ECC risk factors (intervention group) or only to apply fluoride varnish (control group). The study will be conducted in eight Community Health Centers (CHCs) in three states (Massachusetts, Maryland and Ohio), which will be randomized to either the intervention or control groups. These CHCs together serve a range of poor White, African American, Caribbean immigrant and Latino children, groups which are most vulnerable to ECC. Our proposed research will therefore evaluate the efficacy and effectiveness of a training program for pediatric clinicians to administer fluoride varnish and patient centered counseling vs. fluoride varnish alone to reduce the 2-year incidence of ECC among one-year old children, to improve oral health related quality of life in these children, to increase clinician knowledge about ECC, to increase clinician provision of fluoride varnish and counseling to reduce ECC, and to reduce children's exposure to ECC risk factors. As a secondary aim, we will also collect data on the prevalence of ECC among children 3 years old at study baseline, in order to have a comparison group to estimate the overall effectiveness of the multifaceted intervention (i.e., including the effect of the fluoride varnish application) in reducing ECC. Furthermore, we will identify and address the barriers to and facilitators of program dissemination and implementation in both intervention and control sites.